Session (CTI)

Issue China’s biopharmaceutical ecosystem is shifting from a domestically oriented model (“in China for China”) to a bidirectional evidence model, increasingly linking China and ex-China decision making. On one hand, China’s scientific capabilities, accelerated R&D timelines, and expanding pipeline are prompting multinational companies to source Phase 1/2 innovations from Chinese innovators, creating rising demand for China-generated clinical data to support global development (“in China for ex-China”). Clinical trial data from China are increasingly viewed as globally portable when design, execution, and quality standards align, enabling earlier global development, indication expansion, and post-approval commitments. Real-world evidence generated in China, however, is not yet broadly transferable to other jurisdictions for payer decision making. Differences in data provenance, coding, care pathways, and representativeness create a comparability gap. This emerging clinical-versus-real-world dichotomy raises strategic questions about where China evidence can credibly support global value and access today, and what would be required for tomorrow. Overview Presentations (~15 minutes each) will cover: drivers of China’s growing role in globally acceptable clinical evidence and what makes trial data exportable; why China RWE remains limited for ex-China use, and what advances could narrow the gap; and bidirectional frameworks for using ex-China evidence to support China access and China evidence to support global access. Panelists will also discuss how these questions play out in practice from regional biopharmaceutical, academic/policy, and private-sector RWE infrastructure perspectives. The panel will conclude with an audience discussion to surface practical principles and guardrails for integrating China and global evidence streams to improve patient access to innovations.